Clinical trial · Observational
Markerless Image Guidance Using Intrafraction Kolovoltage X-ray Imaging for Lung Cancer Radiotherapy
Validation of Markerless Image Guidance Using Intrafraction Kolovoltage X-ray Imaging Using Implanted Fiducials: Phase I Observational Study of Lung Cancer Radiotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In radiotherapy, tumour tracking allows us to ensure the radiation beam is accurately targeting the tumour while it moves in a complex and unpredictable way. Most tumour tracking techniques require the implantation of fiducial markers around the tumour. Markerless Tumour Tracking negates the need for implanted markers, enabling accurate and optimal cancer radiotherapy in a non-invasive way.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intrafraction Kolovoltage X-ray Imaging | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Markerless Image Guidance | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Markerless Tumour Tracking | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Markerless
- description
- Markerless Tumour Tracking will be used to observe the radiation beam is accurately targeting the tumour.
- interventionNames
- Radiation: Markerless Tumour Tracking
Primary outcomes (1)
- measure
- Markerless Tumour Tracking
- timeFrame
- 6 months after recruitment
- description
- to demonstrate the feasibility of Markerless Tumour Tracking for motion-adaptive lung cancer radiotherapy as assessed by agreement between markerless and marker-based tracking within 3 mm for at least 80% of the beam-on time as assessed in off-line analyses.
Secondary outcomes (12)
- measure
- Markerless Tumour Tracking outcome
- timeFrame
- 6 months after treatment of last fraction
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged 18 or older. 2. Has provided written Informed Consent for participation in this trial and is willing to comply with the study. 3. Patients undergoing external beam radiotherapy. 4. Histologically proven Stage I NSCLC or oligometastatic lung metastases (3 or less). 5. Diagnostic CT prior to insertion of fiducial markers. 6. Patient must be able to have fiducial markers placed in the lung (if on anticoagulants, must be cleared by LMO or cardiologist). 7. ECOG performance status 0-2. 8. A maximum of three metastases to the lung from any non-haematological malignancy. Multiple metastases will be treated separately. 9. 1 cm ≤ Tumour diameter in any dimension ≤ = 5 cm. 10. The distance between the tumour centroid and the top end of the diaphragm is \<=8 cm. Exclusion Criteria: 1. Patient has low respiratory performance as evaluated by the physicians. 2. Previous high-dose thoracic radiotherapy. 3. Less than one fiducial marker implanted in the lung. 4. Fiducial markers are too far from the tumour centroid (\>9 cm). 5. Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. Hormonal manipulation agents are allowable (e.g. aromatase inhibitors, selective oestrogen receptor modulators, and gonadotropin releasing hormone receptor modulators). 6. Targeted agents (such as sunitinib, bevacizumab and tarceva) within 7 days of commencement of treatment, concurrently with treatment or 7 days after radiotherapy. 7. Women who are pregnant or lactating. 8. Unwilling or unable to give informed consent. 9. Unwilling or unable to complete quality of life questionnaires.
References
Publications (0)
Data not yet available